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Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 as Second- or Later- Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Neoplasms, Carcinoma, Non-small Cell Lung

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Trial Information

Phase 2 Study of the Anti-Angiogenesis Agent AG-013736 as Second- or Later- Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer


Inclusion Criteria:



- Histologically documented non-small cell lung cancer with metastases (Stage IV or
recurrent disease) or locally advanced (Stage IIIB) with malignant pleural effusion.

- At least 1 prior systemic therapy for metastatic disease (Prior adjuvant therapy for
localized disease does not count as a prior therapy for metastatic disease).

Exclusion Criteria:

- Central lung lesions involving major blood vessels (arteries or veins). (Central
lesions that maintain the structural integrity of vessels have the potential to bleed
if the tumor lesion undergoes necrosis. MRI or CT angiography should be used in any
case where there is any question as to whether blood vessels are involved.)

- Patients with a history of Grade 2 or worse hemoptysis are not eligible. Patients
with a history of Grade 1 hemoptysis within 30 days of entry are not eligible

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants With Objective Response (OR)

Outcome Description:

Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). PR are those with at least 30 percent (%) decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Outcome Time Frame:

Baseline until the date of first documented progression or discontinuation from the study due to any cause, assessed every 8 weeks up to 98 weeks

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4061011

NCT ID:

NCT00094094

Start Date:

February 2005

Completion Date:

July 2007

Related Keywords:

  • Lung Neoplasms
  • Carcinoma, Non-Small Cell Lung
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Rochester, Minnesota  55905
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Asheville, North Carolina  28801
Pfizer Investigational Site Milwaukee, Wisconsin  53215
Pfizer Investigational Site Bristol, Tennessee  37620